Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study in subjects with asthma

Conditions: Asthma

Summary: the study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (laba), gw642444 in asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment.

the study will be a five-period cross-over study with each 7 day treatment period separated by a 7 day wash-out period. the study will enroll asthmatic subjects ≥18 years of age who are currently receiving inhaled corticosteroid treatment with an fev1 of between 40-85% of predicted normal and with airway reversibility as demonstrated by an increase in fev1 of ≥12% and ≥200ml . efficacy assessments include 24-hour serial lung function testing. safety assessments include incidence of adverse events and measurement of vital signs.

Eligibility criteria:
inclusion criteria: * outpatient * ≥18 years of age at visit 1 * male or eligible female * diagnosis of asthma at least 12 weeks prior to visit 1 * disease reversibility * current anti-asthma therapy * appropriately signed and dated informed consent has been obtained * able to comply with all the study requirements exclusion criteria: * history of life-threatening asthma * no use of systemic corticosteroids for any indication within 8 weeks prior to visit * no concurrent diseases/abnormalities that would put the safety of the subject at risk through study participation * drug allergy to β2 agonist or sympathomimetic drugs, or known or suspected sensitivity to lactose or magnesium stearate * history of severe milk protein allergy * non-compliance with study medication and other study-related requirements * no use of inhaled tobacco products within the past three months or historical use of 10 pack years or more * administration of prohibited medications and non-drug therapies and corresponding timeframes as outlined in the protocol

Keywords: gw642444 once daily dosing asthma efficacy safety fev1
identification and treatment of diabetes in solid organ transplant recipients

Conditions: Complications of Transplanted Organs and Tissue

Summary: the purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.

this study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will: 1. facilitate the adjustment of children and their families to the rigors of diabetes care 2. improve adherence to medication regimens 3. reduce acute complications of diabetes and organ rejection.

Eligibility criteria:
inclusion criteria: * patients of children's healthcare of atlanta who have received a kidney, liver, or heart transplant exclusion criteria: * received a transplant after 18 years of age * cognitively unable to participant as determined by the study team psychologist * not receiving a solid organ transplant for kidney, liver, or heart * declines participation invitation

Keywords: diabetes endocrinology pediatrics
a study assessing kb304 for the treatment of wrinkles in women

Conditions: Wrinkles in Decolletage; Pigmentation; Décolleté Wrinkles

Summary: the aim of this study is to investigate the safety and efficacy of kb304, an investigational gene therapy to correct moderate to severe wrinkles in the décolleté region (v-shaped chest area). kb304 is an investigational gene therapy that delivers functional, full-length human collagen (col3) and elastin (tropoelastin) to the skin through small injections using the sponsor's genetically engineered herpes simplex virus (hsv-1) vector. the study is a randomized double-blind study and participants will receive either kb304 (active group) or placebo (inactive group).


Eligibility criteria:
inclusion criteria: * female in good general health, as determined by the investigator, aged ≥18 and ≤75 at the time of consent. * presence of moderate to severe dynamic wrinkles in the décolleté target area, as determined by the investigator on the jdws. * a fitzpatrick skin phototype score of i-iv. * a negative urine pregnancy test at screening and day 1 (visit 2) for subjects of child-bearing potential. * signed and dated informed consent and willingness to attend all study visits and complete all procedures required by the protocol. exclusion criteria: * any transient or chronic skin condition, disorder, or infection within 20 cm of the target area at day 1 (visit 2) that, in the opinion of the investigator, may interfere with the interpretation of study results. * scars, tattoos or tanned skin (defined as skin that is tanned from sun exposure, tanning beds, or an applied skin color such as a spray tan) within the target area at day 1 (visit 2). * history of laser treatment, microneedling, chemical peels within 3 months of day 1 (visit 2), or botulinum toxin within 6 months of day 1 (visit 2) to the target area. * history of surgical procedures to target area, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may interfere with the interpretation of study results. * administration of a cosmetic and/or investigational agent, in the target area within 6 months of day 1 (visit 2), that, in the opinion of the investigator, may interfere with the interpretation of study results. * any condition (including a history or current evidence of substance abuse or dependence, ongoing systemic infection, infection local to the target area, immunosuppression, or recent history of or active malignancy in the target area) that, in the investigator's opinion, would impact the subject's ability to complete all study-related procedures and/or poses an additional risk to the assessment of safety of the investigational product. * subject who is pregnant or nursing. * subject who is unwilling to comply with contraception requirements per-protocol. * subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the investigator

Keywords: krystal biotech wrinkles in decolletage pigmentation in decolletage décolleté wrinkles
effects of intraarterial octreotide on pancreatic texture

Conditions: Pancreatic Fistula

Summary: the aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy in patients with soft pancreatic tissue hardens the texture of the pancreatic remnant. a primary end-point of the study is a change in pancreatic texture. a secondary end-point is the rate of postoperative pancreatic fistula.

soft pancreas is an established risk factor for the development of postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy. octreotide is believed to harden the pancreas. this theory is based on the results of a single animal experiment and a small case series in humans. this hardening effect of octreotide has not quantitatively been proven in humans and its mechanism is not clear. histomorphologic correlates of pancreatic hardness are unknown. in this study all patients who are eligible for pancreatoduodenectomy and sign the informed consent for participation in the study will be recruited. those of them who prove to have a soft pancreas intraoperatively will receive a single bolus of 500 µg octreotide in the gastroduodenal artery after its proximal division. pancreatic hardness in the region of the resection margin will be quantitatively assessed by a shore durometer before the intervention and at several time-points after it. the suture-holding capacity of pancreatic tissue at the resection margin will be quantitatively assessed by a dynamometer. histomorphological features of pancreatic tissue will be characterized in details at the institute of pathology in order to define possible correlates of pancreatic hardness.

Eligibility criteria:
inclusion criteria: * age between 18 an 90 years * planned pancreatoduodenectomy * signed informed consent * pancreatic hardness equal or less than 40 su as measured by durometer * normal vascular anatomy of the hepato-pancreatic region exclusion criteria: * planned distal pancreatic resection * planned non-resectional pancreatic surgery * acute pancreatitis at the time of surgery * pancreatic hardness before intervention higher than 40 su as measured by durometer * intraoperatively unstable patient * intraoperative complications * allergy towards octreotide * anatomical variation of the vascular supply of the liver or pancreas posing an increased risk for octreotide distribution in other organs than pancreas * lacking gastroduodenal artery or technically impossible cannulation of the artery

Keywords: octreotide intraarterial pancreatic hardness pancreatoduodenectomy durometer dynamometer
could colour dopper improve the diagnosis of retained placental fragments after second trimester miscarriage ?

Conditions: Miscarriage

Summary: value of pelvi- abdominal ultrasound and doppler in diagnosis of retained products of conception after second trimester miscarriage to select who will benefit from surgical evacuations or conservative management.

this is a study for diagnostic accuracy test where all patients will undergo us and doppler examination after second trimester miscarriage. then all patients with endometrial mass on us will undergo colour doppler then surgical evacuation and results of histopathology will be recorded. now, pathological examination of suction evacuation products is considered the gold standard so sensitivity, specificity, ppv and npv of us and doppler are the primary outcome

Eligibility criteria:
inclusion criteria: * pregnancy duration: early mid-trimester from 14 to 20 weeks * endometrial mass upon ultrasound examination after second trimesteric miscarriage exclusion criteria: * uterine congenital anomaly * patients with signs of sepsis. * negative scan after second trimesteric miscarriage
a study of ly3200882 and pembrolizumab in participants with advanced cancer

Conditions: Advanced Cancer

Summary: the main purpose of this study is to see if the drug ly3200882 which is an inhibitor of transforming growth factor-β (tgfβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.


Eligibility criteria:
inclusion criteria: * participants must have received a pd-1 pdli therapy within 9 weeks of starting dosing on this study \[for example, nivolumab, pembrolizumab, atezolizumab\] * participants must be willing to have tumor biopsies * participants must have adequate organ function * participants must have eastern cooperative oncology group (ecog) status of 0 or 1 * participants must be able to swallow tablets * participants with stable, previously treated brain metastases may participate if neurologic symptoms have resolved and participants have been off steroids for at least 14 days exclusion criteria: * participants must not have moderate or severe cardiovascular disease * participants must not have active autoimmune disease (for example crohn's disease, hashimotos disease, etc) * participants must not have an active infection requiring treatment

Keywords: tgf-beta urothelial carcinoma hepatocellular carcinoma non-small cell lung cancer tgf- beta receptor type i inhibitor
evaluation of pain reduction after hemorrhoidectomy with use of diltiazim ointment 2%

Conditions: Pain

Summary: the purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.

pain after hemorrhoidectomy remains a major postsurgical complication.therefore pain management in patients is an important goal.many studies have focused on surgical techniques,preoperative and postoperative regimes.we assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.

Eligibility criteria:
inclusion criteria: * patients with grade 3 or 4 hemorrhoid who underwent milligan-morgan surgery. exclusion criteria: * patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were pregnant.
external beam radiotherapy for muscle invasive bladder cancer

Conditions: Toxicity

Summary: in this phase 1 trial, the investigators will prospectively evaluate 3 different external beam radiotherapy (ebrt) schedules. in every schedule, the whole bladder will be treated to 40 gray (gy) in 20 fractions, 5 fractions/week, 4 weeks in total. based on the summation of abnormalities seen on pre- (initial tumor region) and post transurethral resection zone of fibrosis diffusion weighted-magnetic resonance imaging (mri) images the tumor region is delineated and defined as a gross tumor volume (gtv). the gtv will be treated using a simultaneous integrated boost (sib): without extending the 4-weeks treatment period, 3 different dose levels will be implemented in order to increase the biological equivalent dose (bed), as muscle invasive bladder cancer has been shown to be dose-sensitive.

3 different dose levels will be implemented in order to increase the biological equivalent dose (bed), as muscle invasive bladder cancer has been shown to be dose-sensitive. * level 1: 57.6 gray (gy) (20 x 2.88 gy, 5 fractions/week, 4 weeks); bed: 61 gy. * level 2: 60 gy (20 x 3.00 gy, 5 fractions/week, 4 weeks); bed: 64 gy * level 3: 62.4 gy (20 x 3.12gy, 5 fractions/week, 4 weeks); bed: 67 gy. fiducials will be implanted at the edges of the postoperative bed during the second transurethral resection of the bladder to improve visualization of the gross tumor volume (gtv) during external beam radiotherapy (ebrt) and consequently improve treatment delivery accuracy. in order to further improve the treatment accuracy, 5 planning computed tomographies and plans, with different bladder fillings will be made upfront in our study. during treatment the plan corresponding best with bladder filling at time of ebrt will be selected and delivered.

Eligibility criteria:
inclusion criteria: * histological proven diagnosis of muscle invasive bladder cancer * stage \<t3b tumours with pathological lymph nodes after extended pelvic lymph node dissection * world health organisation performance state 0-2 * signed informed consent exclusion criteria: * contra-indication for diffusion-weighted-magnetic resonance imaging
zenith® p-branch® ots multicenter study

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of the zenith® p-branch® ots multicenter study is to provide an early clinical experience and evaluate the safety and effectiveness of the zenith® p-branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (aaa).


Eligibility criteria:
inclusion criteria: * pararenal or juxtarenal aaa ≥5.0 cm in diameter or 2 times the normal aortic diameter * pararenal or juxtarenal aaa with history of growth ≥0.5 cm/year * saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation exclusion criteria: * age \<18 years * life expectancy \<2 years * pregnant, breast-feeding, or planning on becoming pregnant within 60 months * inability or refusal to give informed consent by the patient or a legally authorized representative * unwilling or unable to comply with the follow-up schedule * simultaneously participating in another investigative device or drug study. (the patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) * additional medical restrictions as specified in the clinical investigation plan * additional anatomical restrictions as specified in the clinical investigation plan

Keywords: abdominal aortic aneurysm endovascular fenestration juxtarenal off-the-shelf pararenal
clinical trial to to compare of the efficacy and safety of lipilou® 20 mg and lipilou® 10 mg

Conditions: Hypercholesterolemia

Summary: this study was designed to compare the mean percent change of ldl-c between lipilou® 10mg and 20mg group after 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * patients who had hypercholesterolemia with high risk, according to the 2015 korean guidelines for managing dyslipidemia. exclusion criteria: * patients with uncontrolled diabetes mellitus, uncontrolled hypertension, thyroid dysfunction. * patients who are legally unable to participate in clinical trials or who are unable to participate in clinical trials based on investigator's decision.
a long term extension study of ixekizumab (ly2439821) in participants with axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.


Eligibility criteria:
inclusion criteria: * have completed the final study visit in study rhbv (nct02696785), rhbw (nct02696798), or rhbx (nct02757352). (note: participants from study rhbx are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor \[tnf\] inhibitor). * must agree to use a reliable method of birth control. exclusion criteria: * have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered. * have a known hypersensitivity to ixekizumab or any component of this investigational product. * had investigational product permanently discontinued during a previous ixekizumab study. * had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study. * have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol. * are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
ibuprofen-pc compared with ibuprofen in a gi safety trial

Conditions: Osteoarthritis

Summary: to determine the safety and efficacy of 3 x 800 mg/day ibu-pc assessed by endoscopy and incidence of adverse events


Eligibility criteria:
inclusion criteria: * moderate osteoarthritis in the hip and/or knee requiring chronic pain medication * others per protocol exclusion criteria: * sensitivity to nsaids and lecithin * hypertension * history of gi and other specific problems * use of medications and other criteria per the protocol

Keywords: nsaid-pc ibu-pc
women's depression treatment study

Conditions: Depression

Summary: the aim of the women's depression treatment study, based in a community mental health center, is to evaluate the effectiveness of interpersonal psychotherapy-trauma in community settings (ipt-tcs) on improving depression and other psychological and social functioning. ipt-tcs is interpersonal psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings.

evidence-based treatments for depression have rarely been studied in community settings where low-income and ethnic minority patients receive care. among the most in need of effective treatments are depressed women with histories of early interpersonal trauma, who suffer disproportionate burden characterized by chronic depression, multiple comorbidities, and marked interpersonal difficulties. the aim of this randomized controlled trial (rct), based in a community mental health center, is to evaluate the effectiveness of interpersonal psychotherapy-trauma in community settings (ipt-tcs). ipt-tcs is interpersonal psychotherapy with modifications specifically designed for the treatment of depressed patients with trauma histories seen in community settings. this trial (n=180) will compare ipt-tcs to active treatment as usual (tau) for women with major depression and histories of childhood sexual abuse. we hypothesize that ipt-tcs will be more effective than tau in reducing depression at 32-weeks after treatment assignment. improvements in social functioning, health-related functioning, post-traumatic stress symptoms, and mental health functioning are also expected. to monitor post-treatment course, outcome variables will be assessed at 6-month intervals over a 2-year period, and longer-term effects will be examined via repeated-measure analyses. this trial is designed to provide definitive results regarding the effectiveness of ipt-tcs compared to usual care in a community mental health center.

Eligibility criteria:
inclusion criteria: * age 18 or older * current major depression * history of sexual abuse prior to age 18 exclusion criteria: * bipolar disorder * psychosis or schizophrenia * active alcohol or substance abuse
primary & booster immunogenicity study of gsk biologicals' hib-menc versus a licensed men-c vaccine

Conditions: Haemophilus Influenzae Type b; Neisseria Meningitidis

Summary: the purpose of this study is to demonstrate the non-inferiority of the candidate hib-menc conjugate vaccine co-administered with infanrix™-ipv versus a licensed meningococcal serogroup c vaccine co-administered with pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the hib-menc vaccine when given as a booster dose at 12-15 months of age.

this multicenter study is open with respect to the treatment allocation, but double-blind with respect to the hib-menc-tt lots (3 lots). the study will be conducted in two stages. primary vaccination phase: 3 doses hib-menc-tt with infanrix™-ipv or for the control group a licensed men-c vaccine with pediacel™ at 2, 3, 4 months of age; booster/persistence phase: 1 dose hib-menc with priorix™. 4 blood samples of 3.5ml (5ml for the uk subset) are collected (study months 0 \& 3, prior to \& 42 days after the booster).

Eligibility criteria:
inclusion criteria: * healthy male or female, between, and including, 6 and 12 weeks of age. * born after a gestation period between 36 and 42 weeks * vaccination with hepatitis b at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory exclusion criteria: * planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of bacille calmette guerin (bcg) and hepatitis b vaccines. * history of h. influenzae type b and /or meningococcal serogroup c disease. * previous vaccination against meningococcal serogroup c disease, diphtheria, tetanus, pertussis, polio or hib disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection * a family history of congenital or hereditary immunodeficiency * history of any neurologic disorders or seizures * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine